Clinical Quality Assurance Director

hace 5 días

Barcelona, Barcelona, España Novartis Farmacéutica, S. A. A tiempo completo

Job Title: Clinical Quality Assurance Director

Job Summary:

We are seeking a highly experienced Clinical Quality Assurance Director to join our team at Novartis Farmacéutica, S. A. As a key member of our Development Unit Clinical Quality Assurance team, you will be responsible for providing strategic quality oversight on the entire Clinical Trial Process (CTP) for the clinical trials under your responsibility.

Key Responsibilities:

  • Proactively provide strong QA leadership to the business strategy for assigned trials by ensuring considerable organization awareness.
  • Support implementation of the quality strategy within GCT under responsibility.
  • Regularly monitor the implementation of the annual Quality Plan pertaining to the Clinical chapter and ensure that all delayed activities have a documented rationale and appropriate escalation.
  • Ensure adequate oversight of proactive quality risk management process in the overseen areas including quality risk assessments and submission/inspection readiness activities.
  • Provide robust and clear quality oversight in various areas of clinical development.
  • Actively leverage audit/inspection outcomes/trends to sustain improvement in clinical trials conduct.
  • Support continuous improvement initiatives and ensure that areas identified as weaknesses are properly being addressed and executed for sustainability.
  • Be QA point of contact for the defined trials and attend the meetings to ensure quality is embedded in the decision-making processes.

Requirements:

  • Degree in Life Sciences, Pharmacy or Medicines.
  • Extensive years of involvement in regulated activities (GCP/PV), clinical development and/or QA positions.
  • Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.
  • Sufficient years of proven experience in managing projects.
  • Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
  • Strong skills in GCP, quality and/or clinical development.

What We Offer:

  • Competitive Salary
  • Company Pension Plan
  • Life and Accidental Insurance
  • Flexible working hours
  • Hybrid working model
  • Subsidized dining facilities
  • Employee recognition scheme
  • Learning and development opportunities

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